Exhibit 10.1
SETTLEMENT
AGREEMENT
I.
PARTIES
This Settlement Agreement
(“Agreement”) is entered into among the United States
of America, acting through the United States Department of Justice
and the United States Attorney’s Office for the Eastern
District of Pennsylvania, the Office of Inspector General
(“OIG-HHS”) of the Department of Health and Human
Services (“HHS”), TRICARE Management Activity
(“TMA”) and the United States Office of Personnel
Management (“OPM”) (collectively the “United
States”); the Relators as identified in Paragraphs B through
E of the Preamble to this Agreement (“Relators”); and
Cephalon, Inc. (“Cephalon”). Collectively, all of
the above will be referred to as “the
Parties.”
II.
PREAMBLE
As a preamble to this Agreement, the
Parties agree to the following:
A.
At all relevant times, Cephalon, a
Delaware corporation headquartered in Frazer, Pennsylvania,
distributed, marketed and sold pharmaceutical products in the
United States including drugs sold under the trade names of Actiq,
Gabitril and Provigil.
B.
Lucia Paccione filed a qui
tam action in the United States District Court for the
Eastern District of Pennsylvania captioned United States of
America ex rel. Lucia Paccione v. Cephalon, Inc. , Civil
Action No. 03-6268.
C.
Joseph Piacentile filed a qui
tam action in the United States District Court for the
Eastern District of Pennsylvania captioned United States of
America and the States of California, Delaware, Florida, Hawaii,
Illinois, Louisiana, Massachusetts, Nevada, New Hampshire, New
Mexico, Texas, Tennessee and Virginia and the District of Columbia
ex rel. Joseph Piacentile v. Cephalon, Inc., Civil Action
No. 03-6277.
D.
Bruce Boise filed a qui
tam action in the United States District Court for the
Eastern District of Pennsylvania captioned United States of
America; the States of California, Delaware, Florida, Hawaii,
Illinois, Massachusetts, Nevada, New Mexico, Tennessee, Texas,
Virginia, the District of Columbia, and New York; ex rel. Bruce
Boise v. Cephalon, Inc. , Civil Action
No. 04-4401.
E.
Michael Makalusky filed a qui
tam action in the United States District Court for the
District of Massachusetts captioned United States of America ex
rel. Michael Makalusky v. Cephalon, Inc., that action was
transferred to the United States District Court for the Eastern
District of Pennsylvania as Civil Action
No. 05-1904.
The qui tam actions
identified in Paragraphs (B) through (E) will be referred
to collectively as the “Civil Actions.”
F.
Cephalon has entered into a plea
agreement with the United States Attorney for the Eastern District
of Pennsylvania and has agreed to plead guilty, pursuant to
Fed.R.Crim.P. 11 to an Information to be filed in United States
v. Cephalon, Inc. (the “Federal Criminal
Action”) that will allege that Cephalon introduced drugs into
interstate commerce and caused the introduction into interstate
commerce of drugs that were misbranded within the meaning of 21
U.S. C. §§ 331(a), 333(a)(1) and 352(f)(1), in that
Actiq, Gabitril and Provigil were marketed for medical indications
that were not approved by the FDA.
G.
Cephalon has entered into or will be
entering into separate settlement agreements, described in
Paragraph 1(b) below (hereinafter referred to as the
“Medicaid State Settlement Agreements”) with the 50
states and the District of Columbia
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(hereinafter referred to as the “Medicaid
Participating States”) in settlement of the Covered
Conduct;
H.
The United States and the Medicaid
Participating States allege that Cephalon caused claims for payment
for Actiq, Gabitril and Provigil to be submitted to the Medicaid
Program, Title XIX of the Social Security Act, 42 U.S.C.
§§ 1396-1396v (“the Medicaid
Program”);
I.
The United States further alleges
the Cephalon caused claims for payment for Actiq, Gabitril and
Provigil to be submitted to the Medicare program, Title XVIII of
the Social Security Act, 42 U.S. C. §§ 1395-1395ggg; the
TRICARE program, 10 U.S.C. § 1071-1109; the Federal Employees
Health Benefits Program (“FEHB”), 5 U.S.C. §§
8901-8914; the Federal Employees’ Compensation Act Program;
the Postal Service Workers’ Compensation Program; and the
Energy Employees’ Occupational Illness Compensation Program;
and caused purchases of Actiq, Gabitril and Provigil by the
Department of Veterans Affairs (“DVA”); the Defense
Logistics Agency (“DLA”); the Bureau of Prisons
(“BOP”) and the Public Health Service
Entities.
J.
The United States and the Medicaid
Participating States contend they have certain civil claims against
Cephalon, as specified in Paragraph 2 below, for engaging in the
following conduct concerning the marketing, promotion and sale of
Actiq, Gabitril and Provigil (hereinafter referred to as the
“Covered Conduct”):
Between January 1, 2001 and
December 31, 2006 for Actiq and Provigil and between
January 1, 2001 and February 18, 2005 for Gabitril,
Cephalon knowingly and willfully promoted the sale and use of
Actiq, Gabitril and Provigil for certain uses for which the Food
and Drug Administration had not approved (i.e. “unapproved
uses”). The promotion of Actiq, Gabitril and Provigil for
these unapproved uses violated the Food Drug and Cosmetic
Act
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21 U.S.C. § 331 (a), 21 U.S.C.
§ 352(f). In addition, certain of these unapproved uses were
not medically accepted indications for which the United States and
State Medicaid programs approved reimbursement. As a result of
Cephalon’s conduct, Cephalon knowingly caused false and/or
fraudulent claims to be submitted to the United States and the
Medicaid programs and caused the Department of Veterans Affairs,
the Defense Logistics Agency, the Public Health Entities and the
Bureau of Prisons to purchase Actiq, Gabitril and Provigil for
unapproved uses.
K.
The United States also contends that
it has certain administrative claims against Cephalon as specified
in Paragraphs 4-6 below, for engaging in the Covered
Conduct.
L.
This Agreement is made in compromise
of disputed claims. This settlement agreement is neither an
admission of facts nor liability by Cephalon nor a concession by
the United States that its claims are not well founded. With the
exception of such admissions that are made in connection with any
guilty plea by Cephalon in connection with the Federal Criminal
action, Cephalon expressly denies the allegations of the United
States and the Relators as set forth herein and in the Civil
Actions and denies that it has engaged in any wrongful conduct in
connection with the Covered Conduct. Neither this agreement, its
execution, nor the performance of any obligation under it,
including any payment, nor the fact of settlement, is intended to
be, or shall be understood as, an admission of liability or
wrongdoing, or other expression reflecting upon the merits of the
dispute by Cephalon.
M.
To avoid the delay, expense,
inconvenience, and uncertainty of protracted litigation of these
claims, the Parties mutually desire to reach a full and final
settlement as set forth below.
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III.
TERMS AND CONDITIONS
1.
Cephalon agrees to pay to the United
States and the Medicaid Participating States, collectively, the sum
of Three Hundred Seventy-Five Million Dollars ($375,000,000), plus
accrued interest in the amount of 4.0% per annum from
January 1, 2008, and continuing until and including the day
before complete payment is made (the “Settlement
Amount”). Payments shall be made as follows:
(a)
Cephalon shall pay to the United
States the sum of Two Hundred Fifty-Six Million, Two Hundred
Ninety-Eight Thousand, Five Hundred and Seventeen Dollars
($256,298,517), plus accrued interest in an amount of 4.0% per
annum from January 1, 2008, and continuing until and including
the day before complete payment is made (the “Federal
Settlement Amount”). The Federal Settlement Amount shall be
paid by electronic funds transfer pursuant to written instructions
to be provided by the United States. Cephalon agrees to make this
electronic funds transfer no later than seven days after the
Effective Date of this Agreement.
(b)
Cephalon shall pay to the Medicaid
Participating States the sum of One Hundred Sixteen Million, Eight
Hundred Thirty-Three Thousand, Four Hundred and Fifty-Five Dollars
($116,833,455), plus interest accrued thereon at a rate of 4.0% per
annum from January 1, 2008, continuing until and including the
day before complete payment is made (the “Medicaid State
Settlement Amount”), under the terms and conditions of the
Medicaid State Settlement Agreements that Cephalon will enter into
with the Medicaid Participating States. This Medicaid State
Settlement Amount shall be paid by electronic funds transfer
pursuant to written payment instructions from the negotiating team
for the Medicaid Participating States.
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(c)
Cephalon shall pay to the Public
Health Service Entities the sum of One Million, Eight Hundred
Sixty-Eight Thousand and Twenty-Eight Dollars ($1,868,028), plus
interest accrued thereon at a rate of 4.0% per annum from
January 1, 2008, continuing until and including the day before
complete payment is made (the “Public Health Settlement
Amount”) as provided in the written instructions agreed to by
the parties. Cephalon shall distribute each affected Public Health
Service entity its proportionate share of the Public Health
Settlement Amount within 60 days of the Effective Date of this
Agreement.
(d)
Contingent upon the United States
receiving the Federal Settlement Amount from Cephalon, the United
States agrees to pay, as soon as feasible after receipt, Forty-Six
Million, Four Hundred Sixty-Nine Thousand, Nine Hundred
Seventy-Eight Dollars ($46,469,978) to Relator Paccione, plus the
pro rata share of the actual accrued interest paid to the United
States by Cephalon on the amount set forth in paragraph
1(a) above. (“Relators’ Share”).
(e)
Relators have entered into a
separate agreement concerning the allocation of the Relators’
Share among themselves.
2.
Subject to the exceptions in
Paragraph 7 below (concerning excluded claims), in consideration of
the obligations of Cephalon in this Agreement, conditioned upon
Cephalon’s full payment of the Settlement Amount, and subject
to Paragraph 17 below (concerning bankruptcy proceedings commenced
within 91 days of the Effective Date of this Agreement or any
payment made under this Agreement), the United States (on behalf of
itself, its officers, agents, agencies, and departments) agrees to
release Cephalon, its predecessors, affiliates, divisions, parents,
subsidiaries,
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successors and assigns, and their current and
former directors, officers and employees from any civil or
administrative monetary claim the United States has or may have for
the Covered Conduct under the False Claims Act, 31 U.S.C.
§§ 3729-3733; the Program Fraud Civil Remedies Act, 31
U.S.C. §§ 3801-12; the Civil Monetary Penalties Law, 42
U.S.C. § 1320a-7a; any statutory provision applicable to
federally-funded programs in this agreement for which the Civil
Division of the Department of Justice has actual and present
authority to assert and compromise pursuant to 28 C.F.R.
Part O, Subpart I, Section 0.45(D) (1995) or the
common law theories of payment by mistake, unjust enrichment and
fraud.
3.
Subject to the exceptions in
Paragraph 7 (concerning excluded claims), below, in consideration
of the obligations of Cephalon in this Agreement, conditioned upon
Cephalon’s full payment of the Settlement Amount, Relators,
for themselves and for their heirs, successors, attorneys, agents,
and assigns, agree to release Cephalon, its parents, subsidiaries,
related entities, officers, directors, trustees, agents, servants,
employees, representatives, attorneys, consultants, successors,
heirs, executors, administrators and assigns, individually and
collectively, current or former, from any civil monetary claim the
United States has or may have for the Covered Conduct under the
False Claims Act, 31 U.S.C. §§ 3729-3733, but expressly
reserve claims they may assert under 31 U.S.C. §
3730(d) for expenses, attorney fees and costs.
4.
In consideration of the obligations
of Cephalon set forth in this Agreement, and the Corporate
Integrity Agreement entered into between OIG-HHS and Cephalon,
conditioned on Cephalon’s payment in full of the Settlement
Amount, and subject to Paragraph 17 below (concerning bankruptcy
proceedings commenced within
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91 days of the Effective Date of this Agreement
or any payment under this Agreement), the OIG-HHS agrees to release
and refrain from instituting, directing, or maintaining any
administrative action seeking exclusion from the Medicare,
Medicaid, or other Federal health care programs (as defined in 42
U.S.C. § 1320a-7b(f)) against Cephalon under 42 U.S.C. §
1320a-7a (Civil Monetary Penalties Law), or 42 U.S.C. §
1320a-7(b)(7) (permissive exclusion for fraud, kickbacks or
other prohibited activities), for the Covered Conduct, except as
reserved in Paragraph 7, (concerning excluded claims), below, and
as reserved in this Section.
In consideration of the obligations
of Cephalon set forth in this Agreement, and the Corporate
Integrity Agreement entered into between OIG-HHS and Cephalon,
conditioned on Cephalon’s payment in full of the Settlement
Amount, and subject to Paragraph 17 below (concerning bankruptcy
proceedings commenced within 91 days of the Effective Date of this
Agreement or any payment under this Agreement), the OIG-HHS agrees
to release and refrain from instituting, directing, or maintaining
any administrative action seeking exclusion from the Medicare,
Medicaid, or other Federal health care programs (as defined in 42
U.S.C. § 1320a-7b(f) against Cephalon under 42 U.S.C.
§ 1320a-7(b)(1) permissive exclusion for conviction
relating to fraud) or 42 U.S.C. §
1320a-7(b)(3) (permissive exclusion for misdemeanor conviction
relating to controlled substance), based on the Federal Criminal
Action referenced in Paragraph F, except as reserved in paragraph 7
(concerning excluded claims), below, and as reserved in this
Section.
The OIG-HHS expressly reserves all
rights to comply with any statutory obligations to exclude Cephalon
from the Medicare, Medicaid, or other Federal health
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